Xinnate Receives FDA Rare Pediatric Disease Designation for TCP-25 for the Treatment of Epidermolysis Bullosa

Press Release 2nd September 2026 Xinnate AB SmiLe Incubator at Medicon Village Scheelevägen 2 223 81 Lund, Sweden Email: [email protected] Website: www.xinnate.com Reg.No. 559201 -3857 Press Release 2nd September 2026 Xinnate AB SmiLe Incubator at Medicon Village Scheelevägen 2 223 81 Lund, Sweden Email: [email protected] Website: www.xinnate.com Reg.No. 559201 -3857 Xinnate Receives FDA Rare Pediatric Disease Designation for TCP-25 for the Treatment of Epidermolysis Bullosa Xinnate AB, a Swedish clinical -stage biotechnology company developing novel therapies based on its groundbreaking peptide technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TCP -25 for the treatment of Epidermolysis Bullosa (EB). TCP -25 has previously been granted Fast Track Designation by the FDA for this indication. Lund, 30th January 2026 TCP-25 is an investigational peptide -based topical therapy designed to treat patients suffering from EB, a rare and serious genetic disease characterized by extremely fragile skin. EB often presents in early childhood and can lead to severe wounds, chronic pain, and life -threatening complications. The FDA grants Rare Pediatric Disease Designation to therapies intended to treat serious or life - threatening diseases that primarily affect individuals under the age of 18. In addition to Fast Track status, which enables more frequent interactions with the FDA and the potential for expedited development and review, the Rare Pediatric Disease Designation provides the opportunity to qualify for a Priority Review Voucher (PRV) upon regulatory approval. A PRV may be used to obtain priority review for another marketing application or transferred to another sponsor. “Together with the Fast Track Designation granted earlier this year, this recognition underscores both the significant unmet medical need for children living with EB and the potential of TCP-25 to address this devastating condition” says Helene Hartman, Chief Executive Officer of Xinnate AB. “We remain committed to advancing our clinical program as efficiently as possible to bring a meaningful treatment option to patients and their families.” In January 2026, Xinnate announced the initiation of its Phase 2/3 STEP study, with the first patient enrolled. The STEP study is a global, randomized, placebo -controlled clinical trial evaluating the safety and efficacy of TCP -25 gel in patients with EB. The study has received regulatory approval in the European Union, where several clinical sites are active and enrolling patients. In the United States, the study has received IND approval, and clinical sites are currently in the start -up phase. Press Release 2nd September 2026 Xinnate AB SmiLe Incubator at Medicon Village Scheelevägen 2 223 81 Lund, Sweden Email: [email protected] Website: www.xinnate.com Reg.No. 559201 -3857 Press Release 2nd September 2026 Xinnate AB SmiLe Incubator at Medicon Village Scheelevägen 2 223 81 Lund, Sweden Email: [email protected] Website: www.xinnate.com Reg.No. 559201 -3857 For more information Helene Hartman, CEO [email protected] About Xinnate AB Xinnate is a Swedish clinical -stage drug development company developing novel therapies based on its unique, groundbreaking peptide technology. These therapies address dysfunctional healing by modulating the interaction between microbes and inflammatory processes. With an ambitious development program, Xinnate is dedicated to improving the lives of, primarily, patients with Epidermolysis Bullosa. Xinnate is a member of the SmiLe Venture Hub at Medicon Village in Lund. www.xinnate.com About TCP-25 TCP-25 is a novel immunomodulatory peptide with demonstrated anti -inflammatory, antimicrobial, and wound -healing properties. Xinnate’s lead drug candidate, TCP -25 gel, is a topical formulation developed for the treatment of Epidermolysis Bullosa (EB). About the STEP study The STEP study, protocol number TCP25 -002, is a double -blind, randomized, placebo - controlled study designed to evaluate the efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed dystrophic EB (DEB) or junctional EB (JEB). The study uses intra-individual randomization, meaning that a pair of matched index wounds are randomized to local treatment with either TCP -25 gel or placebo. Approximately 32 patients from 4 years of age will be included in the study. The study i s conducted in France, Greece, Italy, Spain, Sweden, and the United States. For more information about the study, please see www.clinicaltrials.gov , ID: NCT06594393.

The release as fetched from its publisher. xinnate.com ↗